Date: 2017-09-29
Type of
information: update on patient enrollment
phase: 3
Announcement: update
Company: Formycon (Germany) bioeq GmbH (Germany)
Product: FYB201 (biosimilar ranibizumab ) biosimilar version of Lucentis®
Action
mechanism:
- monoclonal antibody/biosimilar. Ranibizumab is a VEGF inhibitor specifically designed for use in the eye to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
- At the end of 2013, Formycon licensed FYB201 exclusively to Santo Holding GmbH, Holzkirchen. bioeq GmbH, a subsidiary of Santo Holding GmbH, is the sponsor of the Phase III study and is also responsible for the global marketing and licensing of FYB201.
Disease: wet age-related macular degeneration (wet AMD)
Therapeutic
area: Ophtalmological diseases
Country:
Trial
details:
Latest
news:
-
• On September 29, 2017, Formycon announced that Phase III of the clinical trial involving the furthest-advanced biosimilar candidate FYB201 is continuing to progress as planned. FYB201 is a biosimilar candidate for the ophthalmic agent Lucentis®* (ranibizumab) and is scheduled to be marketed in the US from mid-2020 under the responsibility of the licensing partner following successful approval and expiry of the reference product’s legal protection.
- • On February 23, 2016, Formycon and bioeq announced that they have enrolled the first patient in their clinical Phase III study involving FYB201, Formycon’s biosimilar version of Lucentis®. The objective of the study is to demonstrate the comparability of FYB201 and Lucentis® in terms of safety, effectiveness, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD). This condition, known as wet AMD, is one of the primary causes of loss of vision in people over the age of 60 in developed countries. It is estimated that as many as 7.5 million people worldwide suffer from wet AMD. Germany alone has around 450,000 patients with the condition.
- • On October 7, 2015, Formycon and bioeq announced the initiation of a pivotal Phase III clinical trial with FYB201, an investigational biosimilar ranibizumab (Lucentis®). The global clinical trial is designed to confirm biosimilarity with regard to safety, efficacy and immunogenicity of FYB201 versus Lucentis® in patients with neovascular age-related macular degeneration (nAMD). The study design was developed in consultation with the FDA and the European Medicines Agency and is expected to support the registration in both regions.
Is
general: Yes
